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临床试验/NCT02085382
NCT02085382已完成3 期

A Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Low Birth Weight Neonates Admitted in Level II Neonatal Intensive Care Unit of the Philippine General Hospital

University of the Philippines2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
52
试验地点
2
主要终点
Low Birth Weight

研究概览

简要总结

A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness in increasing the rate of weight gain among low birth weight neonates.

详细描述

A randomized, controlled trial of Kangaroo Mother Care (KMC) versus Conventional Care to determine the effectiveness of KMC in increasing the rate of weight gain among low birth weight neonates and if it will decrease sepsis rate and shorten hospital stay among the group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • birth weight <1500 grams and stable neonates (no dependency on oxygen and /or intravenous fluid, ability (at least partial) to feed) with stable vital signs for the past 24 hours (normal temperature (36.5-37.5 °C),
  • normal heart rate (120-160 bpm), normal blood pressure per age
  • no intravenous lines or with well-secured peripheral line
  • no sepsis
  • no emerging signs of sepsis
  • on IV antibiotic therapy but clinically stable
  • can require photo therapy but with stable and not rising total serum bilirubin (TSB) level or TSB is not in high risk zone.

排除标准

  • neonates with chromosomal and life threatening congenital anomalies, who were severally ill
  • whose mothers are critically ill and whose mothers were unable to comply with the follow up schedule.

结局指标

主要结局

Low Birth Weight

时间窗: 3 days

Low-birth weight infants both in the intervention and control group were discharged from the study according to the following criteria: baby's general health was good as assessed by the attending physician and in evidence of infection, feeding well and receiving exclusively breast milk, gaining weight (at least 15-20 grams/kg/day for at least 3 days), maintaining body temperature satisfactorily for at least 3 consecutive days in room temperature and the mother and family members were confident to take care of the baby in KMC.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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